QA/QC

QA-Core Roles Batch Record Review: Check and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) to ensure all processing parameters meet set standards. Line Clearance: Perform physical and procedural checks on the manufacturing or packaging floor before starting a new batch or product.SOP Management: Draft, review, issue, and archive Standard Operating Procedures (SOPs) and other quality documents.Deviation and CAPA Support: Help investigate manufacturing deviations, log incidents, and assist senior staff in tracking Corrective and Preventive Actions (CAPA).Floor Compliance (IPQA): Monitor shop-floor activities like dispensing, granulation, compression, or filling to ensure daily GMP adherence.Audit Preparation: Participate in internal quality audits and help organize documents for regulatory inspections by agencies like the FD.GMP Knowledge: A solid grasp of Good Manufacturing Practices and regulatory guidelines
QC-Sample Analysis: Test raw materials, intermediates, APIs, and finished goods using wet chemistry and instruments like HPLC, GC, and UV-Vis spectrophotometers.Sample Analysis: Test raw materials, intermediates, APIs, and finished goods using wet chemistry and instruments like HPLC, GC, and UV-Vis spectrophotometers.Data Recording: Record test data accurately in workbooks or electronic systems while following Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).Compliance & Safety: Follow Standard Operating Procedures (SOPs) strictly and maintain a safe, clean lab environment.Support Investigations: Help senior staff and Quality Assurance (QA) teams look into out-of-specification (OOS) results or lab deviations.Hands-on operation of analytical tools like HPLC or dissolution apparatus.Clear understanding of GMP and GLP guidelines

Work arrangement
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